The SmPC is part of a medicine's marketing authorization and follows a standard structure, with its content set out in Article 11 of Directive 2001/83/EC. The package leaflet and the labeling on the packaging have to be consistent with it, and its approved text is the reference when labeling changes are made through variations.

Why it matters for labeling

Promotional materials in the EU have to comply with the particulars in the SmPC (Article 87(2) of the Directive), which makes it the source against which claims are checked. Any statement on a label, leaflet or promotional piece that goes beyond or contradicts it is a risk. The US equivalent is the FDA-approved prescribing information.

Common mistakes

  • Claims worded more strongly than the SmPC supports
  • Leaflet or label text not updated after a variation
  • Working from an outdated SmPC version
  • Translated versions that drift from the approved text

Sources